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Trial record 76 of 988 for:    Heparin sodium

Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT02940444
Recruitment Status : Unknown
Verified October 2016 by Yi-Dan Lin, West China Hospital.
Recruitment status was:  Recruiting
First Posted : October 21, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Yi-Dan Lin, West China Hospital

Brief Summary:
Thromboembolism is an important perioperative complication in major thoracic surgery, even though current guidelines have recommended postoperative administration of heparin or LMWH for thromboprophylaxis for those high-risk patients, there are still many cases of thromboembolism. Therefore, as the guideline itself writes, the investigators believe the rational of dose and timing of heparin in thoracic surgery are still not well established. Therefore, the investigators aimed to conduct this randomized controlled study to explore the safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery.

Condition or disease Intervention/treatment Phase
Thromboprophylaxis Thoracic Surgery Drug: Heparin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: case group
start heparin sodium (5000IU, BID) upon admission, and continue until discharge
Drug: Heparin
Active Comparator: control group
start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge
Drug: Heparin



Primary Outcome Measures :
  1. intraoperative bleeding volume (ml) [ Time Frame: the bleeding volume (ml) during operation in the operation room for all patients ]
    During the operation, the blood loss of each patient was collected and measured, and recorded by the investigators.

  2. chest tube drainage volume (ml) [ Time Frame: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy ) ]
  3. thromboembolism occurence rate (%) [ Time Frame: within 30 days after surgery ]
  4. APTT (s) [ Time Frame: on postoperative day 1 for both group ]
  5. PT(s) [ Time Frame: on postoperative day 1 for both group ]
  6. INR [ Time Frame: on postoperative day 1 for both group ]
  7. blood platlet count(/L) [ Time Frame: on postoperative day 1 for both group ]
  8. chest tube drainage duration (days) [ Time Frame: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy ) ]

Secondary Outcome Measures :
  1. PT(s) [ Time Frame: rightly upon hospital admission day ]
  2. APTT(s) [ Time Frame: rightly upon hospital admission day ]
  3. INR [ Time Frame: rightly upon hospital admission day ]
  4. blood platlet count(/L) [ Time Frame: rightly upon hospital admission day ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-75 years old without any preoperative VTEs;
  • patients undergoing major thoracic surgery (including lobectomy, esophagectomy, and thymectomy).

Exclusion Criteria:

  • patients with coagulation disorders: preoperative international normalized ratio (INR) > 1.5, or blood platelet count < 50x10^9/L;
  • patients receiving any therapeutic anticoagulation preoperatively;
  • patients with severe renal or liver dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940444


Contacts
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Contact: Yi-Dan Lin, MD +86 18980602136 hanyudeng@stu.scu.edu.cn
Contact: Han-Yu Deng, MD +86 18200295920 907151184@qq.com

Locations
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China, Sichuan
Department of thoracic surgery, west china hospital, sichuan university Recruiting
Chengdu, Sichuan, China, 610041
Contact: Han-Yu Deng, MD    +86 18200295920    907151184@qq.com   
Principal Investigator: Yi-Dan Lin, MD         
Sponsors and Collaborators
West China Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi-Dan Lin, proffessor, West China Hospital
ClinicalTrials.gov Identifier: NCT02940444     History of Changes
Other Study ID Numbers: WCH-20160601
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action